Cord blood transplantation with a specific conditioning regimen and post-transplant treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the outcomes of cord blood transplantation using a myeloablative conditioning regimen combined with post-transplant cyclophosphamide for preventing graft-versus-host disease (GVHD). The primary focus is on assessing neutrophil and platelet engraftment, as well as CD4+ cell counts at day +100 post-transplant. Secondary objectives include measuring the incidence and severity of both acute and chronic GVHD. The study aims to provide insights into alternative approaches for T cell depletion in cord blood transplantation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age: ≥ 18 ≤ 75 years old
* CB unit transplantation (TNC\> 2,0 x10\^7/kg and \> 4/6 loci HLA matched)
* Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine
* GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF
* Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.

Exclusion Criteria:

* Positive serologic markers for human immunodeficiency virus (HIV)
* Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection

Where it's running

• Fondazione Policlinico Universitario A. Gemelli IRCCS
  Roma, Rm, Italy Recruiting

Study contacts

• Principal investigator: Patrizia Chiusolo, MD — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Study coordinator: Andrea Bacigalupo, Prof.
• Email: andrea.bacigalupo@unicatt.it
• Phone: 0630154180

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.